Clareon Toric Single Arm Study (T2-T9)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 11
- 主要终点
- Mean monocular best corrected distance visual acuity (BCDVA)
研究概览
简要总结
The purpose of this post-market study is to describe the long-term safety and performance of Clareon Toric Intraocular Lenses (IOLs).
详细描述
Subjects will attend up to 12 scheduled visits (one preoperative visit, up to two surgical visits, and up to 9 postoperative visits) over the course of the study. The overall study duration is expected to be approximately 2 years. This study will be conducted in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign the informed consent form.
- •Willing and able to attend all scheduled study visits as required per protocol.
- •Cataract in one or both eyes with planned extraction by conventional phacoemulsification.
- •Astigmatism in the operative eye(s).
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential, currently pregnant, intend to become pregnant during the study, or nursing.
- •History of retinal detachment, age-related macular degeneration, glaucoma, diabetic retinopathy, or any pathologic changes associated with the optic nerve.
- •Clinically significant corneal disease that may, according to the Investigator's medical opinion, adversely affect visual outcomes.
- •Clinically significant dry eye that would affect study measurements based on the Investigator's expert medical opinion.
- •History of prior intraocular or corneal surgery.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Clareon Toric IOL
Clareon Toric IOL implanted in one or both eyes during cataract surgery
干预措施: Cataract surgery (Procedure)
Clareon Toric IOL
Clareon Toric IOL implanted in one or both eyes during cataract surgery
干预措施: Clareon Toric IOL (Device)
结局指标
主要结局
Mean monocular best corrected distance visual acuity (BCDVA)
时间窗: Month 6, Year 1, Year 3 (post implantation)
Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).
Mean monocular best corrected distance visual acuity (BCDVA)
时间窗: Month 6, Year 1
Visual acuity will be assessed for each eye individually using letter charts and recorded in logarithm minimum angle of resolution (logMAR).
次要结局
- Mean absolute IOL rotation from previous visit(Month 1 to Month 3, Month 3 to Month 6, Month 6 to Year 1, Year 1 to Year 3 (post implantation))
- Mean absolute IOL rotation from end of surgery supine baseline to each subsequent visit(Baseline, Day 1, Week 1, Month 1, Month 3, Month 6, Year 1, Year 3 (post implantation))
- Mean monocular absolute residual refractive cylinder(Month 3, Month 6, Year 1, Year 3 (post implantation))
- Mean monocular absolute residual refractive cylinder(Month 3, Month 6, Year 1)